The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Thermodilution Cardiac Output.
| Device ID | K841967 |
| 510k Number | K841967 |
| Device Name: | DESERET THERMODILUTION CARDIAC OUTPUT |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PARKE-DAVIS CO. 2337 PARKDALE AVE. Brookville, Ontario, CA K62 5ws |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-15 |
| Decision Date | 1985-08-19 |